Trial Outcomes & Findings for Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections (NCT NCT00801099)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

276 participants

Primary outcome timeframe

within 30 days postoperative

Results posted on

2015-08-07

Participant Flow

All consecutive patients older than 15 years admitted for clean or clean-contaminated (according to Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp.Epidemiol. 1999;20:250-78) interventions.

Participant milestones

Participant milestones
Measure	Amoxicillin/Clavulanic Acid Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Overall Study STARTED	276
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	101

Reasons for withdrawal

Reasons for withdrawal
Measure	Amoxicillin/Clavulanic Acid Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Overall Study Lost to Follow-up	101

Baseline Characteristics

Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amoxicillin/Clavulanic Acid n=276 Participants Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Age, Continuous	32 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	230 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment Tanzania	276 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days postoperative

Outcome measures

Outcome measures
Measure	Amoxicillin/Clavulanic Acid n=175 Participants Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Number of Participants With Surgical Site Infections	11 participants

SECONDARY outcome

Timeframe: during 3 month of study phase

Outcome measures

Outcome data not reported

Adverse Events

Amoxicillin/Clavulanic Acid

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Amoxicillin/Clavulanic Acid n=276 participants at risk Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Surgical and medical procedures SSI	4.0% 11/276

Other adverse events

Adverse event data not reported

Additional Information

Franziska Saxer, MD

Swiss Tropical Institute

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place